The business and culture of our digital lives, from the L.A. Times

FDA proposes regulation of mobile healthcare apps

July 19, 2011 | 6:01
pm

The Food and Drug Administration has introduced a proposal that would allow it to regulate smartphone and tablet apps that relate to health and medical needs.

The FDA on Tuesday said it would seek "input on its proposed oversight approach for certain mobile applications specific to medicine or healthcare called mobile medical applications ('apps') that are designed for use on smartphones and other mobile computing devices."

The agency said in a statement that its proposed approach "encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets."

"The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery," said Jeffrey Shuren, who directs the FDA's Center for Devices and Radiological Health, in the statement. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended."

The mobile applications the FDA is eyeing for regulation include those that "are used as an accessory to [a] medical device already regulated by the FDA," such as apps that allows doctors to make a specific diagnosis by viewing a medical image on a smartphone or tablet, the FDA said.

Also included would be apps that "transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices" such as those that can turn a smartphone "into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack," the statement said.

The next step? The FDA is looking for the public to comment and weigh in on its app regulation proposals.